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Ldr Spine USA

US

Last updated May 23, 2026

What Ldr Spine USA makes

Ldr Spine USA manufactures spinal implant devices, including polymeric and metal-polymer composite spinal fusion cages, bone-screw internal fixation systems (both sterile and non-sterile), reusable surgical implant templates, and reusable bone tools like levers, elevators, and files. Their portfolio also includes spinal implant trial devices and specific product lines such as the C-Plate, ROI-A, ROI-C, ROI-T, Avenue L, and FacetBRIDGE.

The company’s devices are regulated under FDA classifications including Class I, Class II, Class III, and Unclassified (U), with all products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Ldr Spine USA manufacture?

Ldr Spine USA specializes in spinal implant devices. Their portfolio includes polymeric spinal fusion cages, metal-polymer composite spinal interbody fusion cages, bone-screw internal spinal fixation systems (both sterile and non-sterile), reusable surgical implant templates, and reusable bone tools such as levers, elevators, and files. They also produce spinal implant trial devices and specific product lines like the C-Plate, ROI-A, ROI-C, ROI-T, Avenue L, and FacetBRIDGE.

Where is Ldr Spine USA based?

Ldr Spine USA is headquartered in the United States. The company’s location is relevant for regulatory compliance, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA).

Which regulatory registries list Ldr Spine USA’s devices?

Ldr Spine USA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for each product, allowing healthcare providers and regulators to identify and verify the devices in use.

How are Ldr Spine USA’s devices classified under FDA regulations?

Ldr Spine USA’s devices fall under multiple FDA classifications, including Class I, Class II, Class III, and Unclassified (U). The classification depends on factors like the device’s risk level, intended use, and potential impact on patient safety. For example, reusable surgical tools like bone files or templates may be Class I, while spinal fusion cages or fixation systems could be Class II or III due to their higher risk profiles.

Why do some of Ldr Spine USA’s devices have different sterility classifications?

Ldr Spine USA’s devices are categorized as either sterile or non-sterile based on their intended use and manufacturing processes. Sterile devices, such as polymeric spinal fusion cages or bone-screw fixation systems, are designed for direct implantation into the body and must meet stringent sterilization standards to prevent infection. Non-sterile devices, like reusable bone tools, are intended for single-use in sterile environments or are cleaned and reused, reducing the need for terminal sterilization.

AI-generated from registry data and not verified by a human reviewer.

Information

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US
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Catalogue (3026)

Page 9 of 61
DeviceModel / ReferenceRegistriesClassStatus
Roi-C CMC1431P
FDA UDI
Class IIActive
Roi-A IR2725P
FDA UDI
Class IIActive
Avenue L IR6002T
FDA UDI
Class IIActive
SpineTune TL ST2253T
FDA UDI
Class IIActive
Roi-A IR9397R
FDA UDI
Class IIActive
Mc+ MC918R
FDA UDI
Class IIActive
Roi-C SI-ROIC-0116
FDA UDI
Class IIActive
Roi-C CMC1443P
FDA UDI
Class IIActive
Avenue L IR90132R
FDA UDI
Class IIActive
SpineTune TL ST2253T-S
FDA UDI
Class IIActive
SpineTune TL ST5410T
FDA UDI
Class IIActive
Avenue L IR90259R
FDA UDI
Class IIActive
Easyspine ES919R
FDA UDI
Class IActive
Avenue L IR6912P
FDA UDI
Class IIActive
SpineTune TL ST5428T
FDA UDI
Class IIActive
Avenue L SI-AVEL-0112
FDA UDI
Class IIActive
SpineTune TL ST5505T-S
FDA UDI
Class IIActive
Avenue L IR90236R
FDA UDI
Class IIActive
Avenue L IR6128P
FDA UDI
Class IIActive
Roi-C MC9100R
FDA UDI
Class IIActive
FacetBRIDGE FS4540W
FDA UDI
UActive
Vft VF9161R
FDA UDI
Class IIActive
Roi IR929R
FDA UDI
Class IIActive
VerteFIT VF2102T
FDA UDI
Class IIActive
Avenue L SI-AVEL-0124
FDA UDI
Class IIActive
Roi-A IR9202R
FDA UDI
Class IIActive
SpineTune TL ST5507T-S
FDA UDI
Class IIActive
SpineTune TL ST1551T-S
FDA UDI
Class IIActive
Roi-A IR8233R
FDA UDI
Class IIActive
Avenue L EC014R
FDA UDI
Class IActive
Avenue L IR6330P
FDA UDI
Class IIActive
Avenue L IR7010P
FDA UDI
Class IIActive
FacetBRIDGE FS9000R
FDA UDI
Class IActive
Avenue L IR90110R
FDA UDI
Class IIActive
FacetBRIDGE FS5515T
FDA UDI
UActive
Roi-C MC1454P
FDA UDI
Class IIActive
SpineTune TL ST1455T-S
FDA UDI
Class IIActive
Roi-A IR5421P
FDA UDI
Class IIActive
Mc+ MC353P
FDA UDI
Class IIActive
Roi-A IR2717P
FDA UDI
Class IIActive
Roi-A IR9340R
FDA UDI
Class IIActive
Easyspine ES503T
FDA UDI
Class IIActive
Roi-T IR9098R
FDA UDI
Class IActive
Avenue T AT0021P
FDA UDI
Class IIActive
Roi-A IR9433R
FDA UDI
Class IIActive
Avenue L IR6108P
FDA UDI
Class IIActive
Avenue L IR90502R
FDA UDI
Class IIActive
Roi-A IR2422P
FDA UDI
Class IIActive
Roi-A IR5213P
FDA UDI
Class IIActive
Avenue L IR90499R
FDA UDI
Class IActive

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Aug 29, 2016Z-0045-2017—terminated

The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle. There have been no reports of patient injury